Ye Gu, Ph.D.

Co-founder and Executive in biologics R&D

Greater Boston

About

Well established function head and project leader in Biologics R&D, from Discovery through Clinical Development. Experienced in areas such as function formation, protein science, biologics characterization and lead selection; In-licensing evaluation; developability assessment; process and analytical development; IND-enabling and filing; CMC and quality control; CQA analysis; CDMO management; external collaboration; PK/PD and Proteomics/Biomarker development; biophysics; chromatography; mass spectrometry.

Experience

  • Co-founder, CTO and Head of Business Development at Crystal Bio Solutions, a member of Crystal Pharmatech
    May 2024 - Present · 2 yrs 2 mos

    Biologics characterization and CMC analysis, Bioanalytical and Biomarker analysis, Quantitative clinical pharmacology

  • Head of CMC Operations at CREATE Medicines
    2023 - 2024 · 1 yr

    Cell therapy and in vivo mRNA LNP therapy (Myeloid merged with Brahma in May 2023)

  • Vice President, Head of Process and Analytics at Brahma (merged with CREATE Medicines)
    2022 - 2023 · 1 yr

    Oversees the discovery and development of multispecific immunotherapeutics from construct design, production, through analytics and characterization, defines company growth strategy, creates integrated project plans, and implements plans to meet business objectives. Founded on the pioneering work of David Baker (University of Washington) and Siddhartha Mukherjee (Columbia University), Brahma Therapeutics is developing novel multispecific immunetherapeutics based on Brahma’s proprietary platform technology, to address significant unmet medical needs in immune oncology field.

  • DynamiCure Biotechnology (1 yr 1 mo)
    • Consultant, Director & Head of Analytical
      2022 - 2022 · Less than a year

    • Director, Head of Analytical
      2021 - 2022 · 1 yr

      Function head, responsible for function establishment, analytical/kinetics/bioassay lab set up, assay development (analytical, biophysics, bioassay) and troubleshooting to support both Research and Development, non-GMP and GMP DS and DP characterization, batch release and stability study, method qualification/validation and CDMO management and tech transfer.

  • Boehringer Ingelheim (8 yrs 1 mo)
    • Principal Scientist
      2017 - 2021 · 4 yrs

      Team Lead and Project Leader in biologics Discovery. Experienced in antibody characterization; bioanalytical method development; immunogenicity prediction and assessment; internal and external collaborations; in-licensing evaluation

    • Senior Scientist
      2013 - 2017 · 4 yrs

      Biotherapeutics discovery, Antibody characterization, project management